Bayer's Third Menopausal Relief Drug Trial Meets Primary Goal, German Conglomerate Seeks FDA Approval For Elinzanetant
Bayer's Third Menopausal Relief Drug Trial Meets Primary Goal, German Conglomerate Seeks FDA Approval For Elinzanetant
Tuesday, Bayer AG (OTC:BAYRY) (OTC:BAYZF) announced topline results of the Phase 3 study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.
周二，拜耳公司（场外交易代码：BAYRY）（场外交易代码：BAYZF）公布了评估在研化合物艾林扎奈坦与安慰剂对比的疗效和长期安全性的3期研究OASIS 3的主要结果。
In this study, elinzanetant met the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 12 compared to placebo.
在这项研究中，elinzanetant达到了主要终点，表明与安慰剂相比，从基线到第12周，中度至重度血管舒缩症状（VMS，也称为潮热）的频率在统计学上显著降低。
The long-term safety profile observed over 52 weeks in the OASIS 3 study is consistent with previously conducted studies and published data on elinzanetant.
在OASIS 3研究中观察到的超过52周的长期安全性概况与先前进行的研究和已发布的有关艾林扎尼坦的数据一致。
Elinzanetant is the first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.
Elinzanetant是第一种双神经激素-1,3（NK-1,3）受体拮抗剂，处于后期临床开发阶段，用于非激素治疗与更年期相关的中度至重度VMS，每天口服一次。
OASIS 3 is the third Phase 3 study in the OASIS clinical development program.
OASIS 3是OASIS临床开发计划的第三项3期研究。
In early 2024, Bayer announced topline data of the first two Phase 3 studies OASIS 1 and 2.
2024年初，拜耳公布了前两项3期研究OASIS 1和2的头条数据。
Elinzanetant met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms from baseline to week 4 and 12 compared to placebo.
Elinzanetant符合两项研究的所有四个主要终点，表明与安慰剂相比，从基线到第4周和第12周，中度至重度血管舒缩症状的频率和严重程度在统计学上显著降低。
Both studies also achieved all three key secondary endpoints, showing a statistically significant reduction in the frequency of VMS from baseline to week 1 and statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo.
两项研究还实现了所有三个关键次要终点，显示与安慰剂相比，从基线到第1周，VMS的频率在统计学上显著降低，睡眠障碍和与更年期相关的生活质量也有统计学上的显著改善。
Reuters highlighted that Bayer previously estimated the blood-thinning drug could have peak annual sales of more than €5 billion, and the menopause drug elinzanetant was given the potential of about a billion dollars or more per year.
路透社强调，拜耳此前估计，这种血液稀释药物的峰值年销售额可能超过50亿欧元，而更年期药物elinzanetant的年销售额可能达到约10亿美元或更多。
Last year, Acer Therapeutics Inc's (OTC:ACER) Phase 2a proof of concept clinical trial of ACER-801 (osanetant) as a potential treatment for moderate to severe VMS associated with menopause did not achieve statistical significance to decrease the frequency or severity of hot flashes in postmenopausal women.
去年，Acer Therapeutics Inc（场外交易代码：ACER）对作为与更年期相关的中度至重度VMS的潜在治疗方法的 ACER-801（osanetant）的2a期概念验证临床试验没有达到统计学意义，无法降低绝经后女性潮热的频率或严重程度。
Photo by ClareM via Shutterstock
照片由 ClareM 通过 Shutterstock 拍摄